Job Description:

Quality Control Analyst II

Job LocationsUS-MA-Watertown Job ID2024-1381

Overview

Be Seen and Heard at EyePoint Pharmaceuticals

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

We See You.

Your wellbeing

Your professional worth

Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

This person will report directly to the quality control manager and will be responsible for all aspects of quality control in respect to clinical trial materials and commercial products as required. This position provides production support for analytical quality control testing of pharmaceutical raw materials and drug products.

The individual will work in the QC laboratory located in Watertown, MA with potential to relocate to the Northbridge, MA QC laboratory when appropriate. The individual will ensure that all products are tested,in accordance with all applicable GxP regulations and guidelines (e.g. 21CFR Parts 11, 210/211, 820, (USP/EP/JP), ICH Guidelines), as well as internal company procedures.

Responsibilities

Primary responsibilities include, but are not limited to, the following:

Individual responsibilities

• Perform QC analytical testing for drug products and raw materials (release and stability samples). Evaluates and reduces QC analytical testing data in a timely manner.
• Perform technical review of QC testing data and external testing data.
• Perform routine Laboratory housekeeping to ensure the maintenance and compliance of laboratory's operational areas.
• Provide support for inspection and testing of incoming raw materials.
• Provide support to analytical development for QC analytical method validation and method transfer.
• Assist in authoring and reviewing standard operating procedures , test methods, and work instructions related to QC activities.
• Assist in QC sample management for internal and external testing samples.
• Prepare reagents and standards per procedure ensuring proper handling, storage and disposal of hazardous materials.
• Provide support for analytical data tracking and trending.
• Work under minimal supervision to ensure all work is performed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.
• Identify laboratory anomalies and/or discrepancies then escalate to management in a timely manner. Work with laboratory personnel and management to address issues.
• Provide support for investigations regarding deviations, out-of-trend (OOT)/out-of-specification (OOS) results
• Provide analytical testing support for development protocols and reports as appropriate
• Assist in development of training programs for QC analysts.
• Perform workload to meet schedules, timelines, deadlines as per procedure's and/or department requirements.
• Support internal and external audits and regulatory inspections, as required.
• Participate as Subject Matter Expert (SME) during Regulatory Inspections, as appropriate.

Qualifications

Primary skills and knowledge required include, but are not limited to the following:

• Experience in analysis of pharmaceutical products by USP/EP methods required.
• Knowledge of cGMPs and related compliance regulations and guidance's is required (e.g. Title 21 CFR Parts 11, 210/211, 820,) USP/EP / ICH Guidelines.
• Hands on experience with analytical chemistry instruments and techniques: High-Performance Liquid Chromatography (HPLC) required. (Empower Software experience is a plus). Experience with basic laboratory equipment such as balances, automatic pipettes, pH meters
• Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently
• Must be a team player with integrity and concern for the quality of Company products, services and staff members.
• A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and suppliers.
• Must have excellent organizational, verbal communication, technical documentation and computer skills.
• Routinely exercises sound judgment, reasoning and problem solving
• Capable of completing assigned responsibilities under minimal supervision and keeping management informed of work status.
• Flexible and able to respond quickly to shifting priorities to meet deadlines.
• Position may involve use of reagents and other chemical compounds that are considered hazardous.
• Ability to communicate and work independently with scientific/technical personnel in both internal and external setting.

Level of Education Required:

Chemistry/Biochemistry or related field.

BS/BA or higher degree or an equivalent combination of education and experience in related field of pharmaceutical or biopharmaceutical industry

Number of Years of Experience in the Function and in the Industry:

3-6 years of demonstrated practical Quality Control experience in GMP regulated laboratory.

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

• Success begins with our People
• Patients First
• Integrity
• Results-Driven
• Innovation
• Team Focus
• Diversity & Inclusion

EyePoint Pharmaceuticals is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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